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Tainted Formula: DOJ Opens Criminal Probe on Abbott After Infant Deaths
The Department of Justice’s consumer-protection branch has opened a criminal investigation into the conduct of Abbott Laboratories, one of the country’s largest formula makers at the center of a contamination scandal and ongoing nationwide shortage.
The existence of the investigation was first reported by The Wall Street Journal. Though the DOJ is not commenting on it, a spokesperson for Abbott said the department has informed them of the investigation and that the company is “cooperating fully.”
Federal regulators last year found numerous violations and “egregiously unsanitary” conditions at Abbott’s Sturgis, Michigan, plant, the largest formula factory in the country. The regulators previously received reports that at least four babies who drank formula made at that facility fell ill with dangerous infections of the bacterium Cronobacter sakazakii, which had also been detected in the plant. Two of the infants died.
The Food and Drug Administration had also received a whistleblower complaint that alleged safety violations, falsifications of records and cover-ups at the facility. But it took several months for that complaint to reach top FDA officials, during which time one infant died and others became ill. The FDA’s clumsy handling of the complaint drew backlash from lawmakers and sparked an outside review of the agency.
Greedy Pharma Firms Rip off Americans While Pfizer, Moderna Swim in Profits
There is a lot of discussion about how “divided” our nation is and, on many issues, that is absolutely true. But on one of the most important matters facing our country the American people — Democrats, Republicans, Independents, Progressives, Conservatives — could not be more united. And that is the need to take on the unprecedented corporate greed of the pharmaceutical industry and substantially lower the outrageously high price of prescription drugs.
All over this country, the American people are asking why it is that they pay, by far, the highest prices in the world for prescription drugs. The answers can be summed up in three words: Follow the money.
Over the past 25 years, the pharmaceutical industry has spent $8.5 billion on lobbying and over $745 million on campaign contributions to buy politicians. Incredibly, last year, the drug companies hired over 1,700 lobbyists including the former congressional leaders of both major political parties — over 3 pharmaceutical industry lobbyists for every Member of Congress.
Meanwhile, as Americans die because they cannot afford the medications they need, five of the largest drug companies in the U.S. made nearly $80 billion in profits last year (a 104% increase from the previous year) while the CEOs of just 13 pharmaceutical companies made over $1 billion in total compensation in 2021.
WHO Urges ‘Immediate Action’ After Cough Syrup Deaths
The World Health Organization (WHO) has called for “immediate and concerted action” to protect children from contaminated medicines after a spate of child deaths linked to cough syrups last year.
In 2022, more than 300 children — mainly aged under 5 — in Gambia, Indonesia and Uzbekistan died of acute kidney injury, in deaths that were associated with contaminated medicines, the WHO said in a statement on Monday.
The medicines, over-the-counter cough syrups, had high levels of diethylene glycol and ethylene glycol.
As well as the countries above, the WHO told Reuters on Monday that the Philippines, Timor Leste, Senegal and Cambodia may potentially be impacted because they may have the medicines on sale. It called for action across its 194 member states to prevent more deaths.
Amazon Launches a $5 Monthly Subscription for Unlimited Prescription Medications
Amazon is launching RxPass in the U.S., a new drug subscription exclusive to Prime members that charges users a $5 monthly fee to ship eligible prescription medications to their doorstep. Announced on Tuesday in a press release, the Amazon RxPass subscription program provides generic medications to treat over 80 common health conditions, including high blood pressure, hair loss, anxiety and acid reflux.
Amazon has launched several healthcare services in recent years. The company closed down its original Amazon Care telehealth program (launched in 2019) in November last year in favor of its newer Amazon Clinic telehealth service. RxPass subscriptions dispense from Amazon Pharmacy — an affordable online pharmacy exclusive to Prime members that launched in 2020.
Big Pharma Groups Rejoin Battle With Governments on Drug Prices
If there was some sort of a truce on drug prices between big pharma and politicians during the coronavirus pandemic, it ended last week in spectacular fashion.
U.S. groups Eli Lilly and AbbVie pulled out of the strictest price regime in Europe — after NHS spending on branded drugs in 2022 handed the industry £3.3bn in clawback costs, about 26.5% of U.K. sales.
Drugmakers are also considering whether to withdraw from an agreement with the French government, according to one person familiar with the discussions. The pharma industry had hoped its role in creating vaccines and drugs that helped lift lockdowns would prove its economic value to politicians, who have often accused it of putting profits before patients.
The biggest pricing shake-up for decades is underway in the U.S. which, according to think-tank Rand, pays about 2.5 times the average drug price paid by a group of 32 comparison countries. From next year, the federal government will, for the first time, have the power to negotiate prices for some of the most expensive treatments purchased by Medicare, the taxpayer-funded healthcare scheme for retirees.
Eli Lilly to Invest $450 Million More to Expand Capacity as Obesity Drug Decision Looms
Eli Lilly and Co. plan to invest an additional $450 million to expand the capacity of a plant in North Carolina, the U.S. drugmaker said on Tuesday, as it races to boost production ahead of a decision on its promising obesity treatment.
The company has been struggling to meet strong demand for its incretin products, which include its blockbuster diabetes drug Trulicity and recently launched Mounjaro. Last month, the U.S. Food and Drug Administration added both to its list of drugs facing shortages.
Trulicity recorded $5.5 billion in sales last year through Sept. 30, but Lilly and investors have pinned their hopes on Mounjaro to drive future growth.
Bayer’s Oncology Business Looks to Collect $10 Billion in Sales by 2030, Exec Says
Last year, former GSK oncology head Christine Roth took on the challenge of leading the oncology group at German pharma giant Bayer. Her task — to push the company further into the lucrative market — has been bolstered by the prostate cancer drug Nubeqa’s second approval and a subsequent sales boost.
Her next mission — to lead the program to $10 billion in sales by 2030 — is even more ambitious.
2022 was an “extraordinary ride,” Roth said of her first ten months at Bayer. Nubeqa’s August FDA nod in metastatic hormone-sensitive prostate cancer pushed the company to raise the drug’s peak sales estimate from more than 1 billion euros to more than 3 billion euros ($3.4 billion).
FTC Accuses ‘Pharma Bro’ Martin Shkreli of Flouting Lifetime Ban From Industry
The Federal Trade Commission asked a judge to hold “Pharma Bro” Martin Shkreli in contempt of court after the infamous fraudster allegedly resisted efforts to determine whether he violated a lifetime ban from working in the pharmaceutical industry.
The agency said Shkreli, 39, hadn’t complied with its requests to submit documents and participate in an interview on his new company Druglike Inc., which “purports to revolutionize early-stage drug discovery through a decentralized computing network.”
Last February, Shkreli was permanently barred from “directly or indirectly participating in any manner in the pharmaceutical industry” — a ban imposed after he was determined to have run an “illegal anticompetitive scheme” to maintain a monopoly on the life-saving drug Daraprim.
In addition to the ban, Shkreli was found liable for $64.6 million in penalties related to his effort to stifle rivals. The FTC said Shkreli has yet to repay any of the money.
Pharma’s Strategy to Exploit a Depression-Era Antitrust Law Would Raise Drug Costs for Consumers
The prescription drug market is bewildering to many, and its complexity can make rational discussions about the causes of high drug prices exceedingly difficult. It also means that government officials regulating the market have to take care that their actions don’t have any unintended consequences. Unfortunately, such unintended consequences are precisely what may transpire in the next two years.
One thing that makes this market complex is that the producers of pharmaceuticals — namely, the drug companies — do not sell directly to the people who ingest the drug. People who need a drug usually get a prescription from their doctor and then go to a pharmacy, where they present their insurance information and make what is usually a nominal co-payment, while their insurer pays most of the costs.
What further complicates this market is that pharmacy benefits managers (PBMs) receive negotiated discounts not in the form of a reduced price per prescription but rather in the form of a rebate. It is done this way because a law requires it: A depression-era piece of legislation called the Robinson-Patman Act prohibits volume discounts in many situations, and that is what PBMs negotiate for.
